Research & Development
Antengene's ATG-101 granted US FDA Orphan Drug Designation
19 September 2022 -

Antengene Corporation Limited, a China-based commercial-stage global biopharmaceutical company, announced on Sunday that it has been granted Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for its ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, intended to treat pancreatic cancer.

The ODD is intended to support the company in facilitating regulatory communication with the FDA, expedite ATG-101's clinical development and its future registration.

ATG-101, a novel PD-L1/4-1BB bispecific antibody, is aimed at blocking the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumour immune effectors, while delivering improved anti-tumour activity, with an improved safety profile. During preclinical studies, the product showcased significant anti-tumour activity in animal models of resistant tumours and those that had progressed on anti-PD-1/L1 treatment. It has also claimed to have demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. It is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is presently being assessed in clinical studies in Australia, China, and the US.

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